An observational study in Breast Implant; Complications, Breast Implant Infection and Implant Capsular Contracture, sponsored by European Institute of Oncology. Completed at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by European Institute of Oncology · Observational
The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss)
The main questions the study aims to answer are:
Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.
Radiotherapy is highly effective in breast cancer treatment, yet it impairs satisfactory implant-based reconstruction, due to high rates of capsular contracture and implant loss. This said, a fervent investigtion exists upon solutions that can make implant-based reconstruction safer and aesthetically satisfying, including the use of acellular dermal matrices. We retrospectively want to analyze our ADM-assisted post-RT implant-based breast reconstructions comparing two different matrices (porcine and bovine), when autologous reconstruction was contraindicated, to assess eventual differences in efficacy and risk profile of the devices. We want to further stratify the population in 4 groups based on clinical presentation to assess if there was a group where ADMs proves to perform better (Group A - previous quadrantectomy, Group B - previous mastectomy and expander reconstruction, Group C - previous mastectomy and implant reconstruction, Group D - prior quadrantectomy followed by mastectomy and implant reconstruction).
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 146 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →European Institute of Oncology is the lead sponsor of 184 studies on the registry; 117 are open to participants now.
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The study focuses on female patients undergoing implant based reconstruction after radiotherapy assisted by the use of an acellular dermal matrix.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Native adm used in the setting of mastectomy and implant reconstruction after QUART
Device: acellular dermal matrix implant for breast reconstruction
Veritas adm used in the setting of mastectomy and implant reconstruction after QUART
Device: acellular dermal matrix implant for breast reconstruction
Native adm used in the setting of expander removal and implant positioning after mastectomy + RT
Device: acellular dermal matrix implant for breast reconstruction
Veritas adm used in the setting of expander removal and implant positioning after mastectomy + RT
Device: acellular dermal matrix implant for breast reconstruction
Native adm used in the setting of implant exchange after mastectomy + RT
Device: acellular dermal matrix implant for breast reconstruction
Veritas adm used in the setting of implant exchange after mastectomy + RT
Device: acellular dermal matrix implant for breast reconstruction
Native adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction
Device: acellular dermal matrix implant for breast reconstruction
Veritas adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction
Device: acellular dermal matrix implant for breast reconstruction
acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
ADM efficacy and risk profile comparison
Does one dermal matrix perform better than the other in terms of efficacy and complication rates?
Time frame: 60 months
Best clinical setting for ADM use
Is there a subgroup of patient where the use of ADM proves more beneficial than others?
Time frame: 60 months
ADM comparison in each clinical setting group
Is there a type of dermal matrix that performs better than the other in a specific subgroup of patients?
Time frame: 60 months
Ran from Jun 2017 to primary completion in Dec 2022, 66 months.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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